The CTSI’s Clinical Research Data Warehouse (CRDW) provides no-cost self-service tools to CITI-trained research teams for study feasibility, cohort discovery and data extraction. CRDW tools include the i2b2 Cohort Discovery Tool, TriNetX (a pharma-sponsored cohort query and analysis tool) and the Honest Broker data extraction tool. Data sources include Epic, GE/IDX (physician billing system), Froedtert legacy systems (Affinity, Intellidose & SIS), MCW Tissue Bank biospecimens, NAACCR tumor registry, and genetic testing vendors (Foundation Medicine and Tempus).
The query tools help to answer the question “Does the CRDW contain a cohort of patients with certain characteristics?”
The i2b2 query tool includes the following concept domains from which researchers can select criteria for cohort characterization.
The TriNetX query tool includes Demographics, Medications, Diagnoses, Diagnostic Testing Results, Procedures and Genomics.
Users of the Clinical Research Data Warehouse acknowledge that:
To use the Medical College of Wisconsin’s Clinical & Translational Research Informatics tools you must:
FOR ALL 5 SCENARIOS BELOW: Investigators that MIGHT utilize CRDW data MUST link their eBridge study applications to the CRDW bank (PRO00013874) in Section 26 of the SmartForm.
Please explain your use of the CRDW using the following templated language within the indicated sections of the IRB application SmartForm… otherwise the IRB will not understand what you are doing and the review of your application, as well as the approval of your data request(s), will be delayed.
I. FOR INVESTIGATORS USING THE CRDW TO IDENTIFY AND/OR CONTACT ELIGIBLE PARTICIPANTS
In the Recruitment section (17.2) of SmartForm, the investigator should check Other Strategies and clearly state how CRDW tools may be used to identify potential participants and gain access to their contact information.
The investigator should state:
“To identify potential participants and obtain their contact information for recruitment, the investigator will (a) search for eligible participants with the following inclusion/exclusion criteria by querying a cohort discovery tool (i2b2 and/or TriNetX) from the MCW Clinical Research Data Warehouse (PRO00013874) , and then (b) seek IRB approval to extract the following contact information for each identified potential participant using the Honest Broker tool:
II. FOR INVESTIGATORS USING THE CRDW TO ACCESS IDENTIFIED DATA WITH OR WITHOUT PARTICIPANT RECRUITMENT
In the Protocol Summary (19.7) or Procedures (30.1) section of the SmartForm, the investigator must clearly state whether the CRDW is the ONLY way potential participants will be identified or the CRDW is ONE OF SEVERAL participant identification strategies.
The investigator should state:
“Clinical data for this study will be obtained by… <indicate one of the following options>
III. FOR INVESTIGATORS USING THE CRDW TO ACCESS FULLY DE-IDENTIFIED DATA OR A LIMITED DATA SET for purposes other than participant recruitment
**Some investigators may not be required to submit anything to the IRB for this scenario – contact CRDW.mcw.edu for guidance. Other investigators may have “mixed” projects involving CRDW de-identified data AND other activities requiring IRB review.**
In the Protocol Summary (19.7) or Procedures (30.1) section of the SmartForm, the investigator must clearly state whether the CRDW is the ONLY way potential participants will be identified or the CRDW is ONE OF SEVERAL participant identification strategies.
The investigator should state:
“Clinical data for this study will be obtained by searching for eligible anonymous participants using a cohort discovery tool (i2b2 and/or TriNetX) from the MCW Clinical Research Data Warehouse (PRO00013874) with (a) the following inclusion/exclusion criteria, and then (b) extracting the following de-identified clinical information for each identified participant:
IV. IMAGE DE-IDENTIFICATON (the most typical situation) the investigator has IRB approval to access identified F&MCW images, but wants them de-identified so the images can be sent outside F&MCW in de-identified format
The investigator should “prove up” to the CRDW gateway that the investigator already has IRB approval to access or use these specific images, and IRB approval for access to IDENTIFIED images. When in doubt, the CRDW can and should always check with an IRB staff person.
The investigator wants to send a scan image to an external party (sponsor, collaborator) de-identified because the STUDY PROTOCOL requires de-identification in this situation, and/or the IRB APPLICATION promised de-identification in this situation, and/or the STUDY CONSENT FORM promised de-identification in this situation. Thus — even though scrutiny of the HIPAA authorization language may show that the participant has in general authorized the investigator to share some identified information with the third party — de-identification of the image scan is still REQUIRED.
In the Procedures section (30.1) of SmartForm, the investigator should state in the IRB application:
“Identified scan images to be provided to XXX and YYY (external third parties) will be totally de-identified per study protocol by submitting index images and destinations to the Honest Broker / Image De-Identification Service of the MCW Clinical Research Data Warehouse and having that Honest Broker send the de-identified images.” [Though it may be clear elsewhere in the protocol, the PI should again state here what kinds of images and how many images will be sent this way.]
V. IMAGE DE-IDENTIFICATION (less common situation) where the investigator wants to use a CRDW cohort discovery tool (i2b2 and/or TriNetX) to identify eligible participants and then have the CRDW deliver de-identified images for that cohort, so the activity (on the part of the PI receiving de-identified images from a valid honest broker) does not technically qualify as “human subjects research.”
In the Procedures section (30.1) of SmartForm, the investigator must clearly state whether the CRDW is the ONLY way potential participants will be identified or the CRDW is one of several participant identification strategies.
The investigator should state in the IRB application:
“Clinical data for this study will be obtained by using a cohort discovery tool (i2b2 and/or TriNetX) from the MCW Clinical Research Data Warehouse (PRO00013874), to (a) search for eligible participants with the following inclusion/exclusion criteria, and then (b) seek IRB approval for this project asking the CRDW to provide the following clinical information and SCANS for each identified participant:
Note: this method of accessing de-identified data may ultimately be deemed “not human subjects research” depending on what else the investigator will be doing.
Investigators must cite both AHW and Medical College of Wisconsin CTSA Grant UL1TR001436.
This includes use of the self-service cohort discovery tool, data consultations, clinical queries, and data extraction services made by our team.
“This project is funded in part by the Advancing a Healthier Wisconsin endowment at the Medical College of Wisconsin.”
Please acknowledge the Medical College of Wisconsin CTSA Grant UL1TR001436. All publications must comply with NIH Public Access Policy.
Each project includes the following training and support:
Any project scope expansion beyond the included 2 hours, as outlined above, is considered out of scope and may affect your data delivery timeline and/or budget.
Additional project support is billed hourly at a rate of $90 per hour ($100/hr effective 7/1/2017). No work on scope changes will be done before both parties agree on cost and timeline changes and are client authorized with approval of a written change order.
Validate a research hypothesis by generating a de-identified cohort
No IRB review required.
Test a QA/QI hypothesis by generating a de-identified cohort
No IRB review required.
Extract de-identified data from Honest Broker for a known cohort or a cohort generated from a query tool such as i2b2 or TriNetX
No IRB review required.
Extract data from Honest Broker for a known cohort or an identified cohort generated using a query tool such as i2b2 or TriNetX
IRB approval required.
Extract data from Honest Broker for a known cohort or an identified cohort generated through i2b2 for QA/QI
Research teams may use the CRDW’s self-service de-identified cohort discovery query tools to curate and iteratively refine cohorts for hypothesis development. Researcher teams may also extract and review de-identified clinical data as a preliminary step before requesting identified data for a research project.
The CTSI Biomedical Informatics team will provide up to 2 hours of complimentary consultation and training to develop queries and/or extracts that meet the specific needs of each research project.
Research teams should define specific inclusion and/or exclusion criteria to build a study cohort within one of the CRDW query tools. This curated cohort can then be used to export various data tables from the Honest Broker extract tool in CSV format. CSV files are compatible for import into many data analysis tools.
De-Identified data extracts should be treated as if they contain real patient data – they must be stored on a secure device or network drive.
Teams who wish to identify the patients in their cohort must apply to the IRB for study approval in order to extract identified patient data.
Research projects wanting to use identified data or a limited data set must have an approved IRB protocol to extract identified data from Honest Broker. Project teams are encouraged to use the de-identified query tools to inform protocol content, i.e. validating the cohort size for Section 3F.
Simply receiving IRB approval does not guaranty Honest Broker approval. There are 5 IRB checkpoints that must be in place on the eBridge SmartForm for a successful Honest Broker submission: Sections 2.1 (team members), 3F (both dates and counts), 19.7/30.1 (process language), and 26.2 (link to CRDW bank).
Existing protocols should be reviewed to ensure all IRB checkpoints are covered. In some cases, the researcher must submit an IRB amendment to include additional elements and/or language. To request a protocol review, please contact CRDW@mcw.edu.
The Medical College of Wisconsin’s Clinical & Translational Research Informatics team offers a number of research data management options in support of clinical research, including: REDCap, and Secure ResearchWiki. We strongly encourage researchers to consult with a biostatistician from the CTSI, CAPS, or MCW’s Institute for Health & Society before beginning the analysis of their clinical data.
Inquiries and consultations on new research projects are offered free of charge to CTSI community researchers. In general, we will provide one hour of labor working on a project before we need to discuss setting up a payment plan.
When additional payment is required, you will be responsible for covering a standard billing rate on an hourly basis for the time spent working on your project.
In projects where Biomedical Informatics expertise is required, we may engage in a collaborative partnership leading to co-authorship on related publications. In such a collaboration, and particularly where the work is of shared interest, we may be able to extend a cost-sharing of services.
We ask that all research related to your consultation include appropriate citations to the resources used. Please see our citation information for details.
To gain access to the Clinical Research Data Warehouse, a PI must complete the following form. The PI must be a registered CTSI member and be designated as Faculty or Adjunct Faculty. In order to grant access to research team members, the PI must provide a name, contact information and project role for each team member on the Project Team form.
Only MCW employees/students/adjunct faculty or CTSI community partners with an MCW Network ID (e.g., an @mcw.edu email address) can be given access to the CRDW.
CRDW Data Release AgreementThis Data Release Agreement (“Agreement”) is by and between The Medical College of Wisconsin, Inc. located at 8701 Watertown Plank Road, Milwaukee, WI 53226 (“MCW”) and (“Recipient”).
RECITALS
WHEREAS, MCW is a freestanding academic medical center with the missions of patient care, education, research and community engagement;
WHEREAS, MCW owns and maintains the Clinical Research Data Warehouse (“CRDW”) in which certain clinical data, obtained from the electronic health records of patients of MCW and one or more MCW affiliate(s), are stored for use in research; and
WHEREAS, Recipient is an MCW employee and desires to obtain the CRDW data (“Data”) described in the Data Request Form submitted to and approved by MCW (“Request Form”) for use in the research study(ies) listed on the Request Form (“Research Study”), and MCW desires to provide the same to Recipient in furtherance of its missions.
NOW THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto, intending to be legally bound, agree as follows:
1. Purpose. This Agreement governs the terms and conditions under which MCW shall provide to Recipient the Data listed in the Request Form, attached hereto as Exhibit A and incorporated herein by reference. Recipient agrees to use the Data only for use in the Research Study and pursuant to the terms of this Agreement.
2. Rights in the Data.
2.1 Any and all rights in and to the Data are retained by MCW. MCW grants to Recipient a limited, non-exclusive, non-transferrable license to use the Data for use in the Research Study and in accordance with the terms and conditions stated herein. This Agreement is not intended to and shall not be construed to grant, license or transfer ownership of any rights to Recipient or any other third party other than that which is expressly provided herein.
2.2 For the avoidance of doubt, Recipient shall not disclose, assign, sell, distribute, lease, rent, sublicense or transfer the Data (or any of its data elements) or this Agreement to any other person or third party other than to those individuals listed on the Request Form.
2.3 Recipient agrees to notify its Department Chair immediately of any unauthorized disclosure, assignment, sale, distribution, lease, renting, sublicensing, transfer or use of the Data or any of its data elements. Recipient, the Department Chair and the Senior Associate Dean for Research shall then confer on actions and remedies.
3. Access to patient-identified data. MCW shall only make patient-identified data available to Recipient after receiving documentation of MCW/FH Institutional Review Board (IRB) approval or deferral for the Research Study. If approved or deferred by MCW /FH IRB, and documented and justified in the Request Form, these Data may be linked to other data sets, consistent with the applicable research protocol (“Protocol”).
4. IRB Approval. Recipient acknowledges and accepts responsibility for submitting the Research Study Protocol to the IRB-of-Record for approval or exemption determination. Recipient shall be solely responsible for continued compliance with applicable IRB policies and procedures, and applicable laws, for the duration of the Research Study. Recipient must notify the CRDW of any changes or amendments to the Research Study Protocol.
5. Progress Reports. Upon request, Recipient will provide to the CRDW a progress report on the Research Study and a description of how compliance with the terms of this Agreement has been maintained. The CRDW reserves the rights to: request clarification on any of the submitted information, request additional related information (including the Data use logs referenced in below), and/or conduct an audit at a reasonable time and date, of any information in Recipient’s possession or control related to the Data, this Agreement, and the Research Study.
6. Data Use.
6.1 Recipient shall not use Data to identify individuals, and will not link or combine the Data with other patient-level information, unless first approved in the Request Form. In the event the originally approved Request Form does not contemplate linking or combining Data in this manner, and Recipient later desires to do so, the Request Form must be updated and subsequently submitted to and approved by the CRDW before such linking or combining may occur. Recipient is solely responsible for updating any Protocols to provide for such linking or combining, in accordance with IRB policies and procedures.
6.2 Recipient shall keep an accurate written account of all authorized copies of the Data, and of work product derived from the Data, and will furnish such written logs upon the CRDW’s request to the CRDW.
6.3 Recipient shall use the Data solely for the research purposes set forth in the Request Form and its attachments (including the Protocol), and specifically shall not use the Data for any commercial purpose, including but not limited to that which could have a negative impact on patient welfare, such as offering, denying, or allocating insurance; and adverse selection (e.g., identifying patients with high risk diagnoses).
6.4 Recipient may make one copy of the Data for its records, but Recipient shall not make any additional copies of the Data for any other purpose, and shall not sell or license the Data or information derived from the Data. However, Recipient may release Data or information derived therefrom to a subcontractor for purposes of processing or storage if: (a) the Protocol provides for the same and is approved by the IRB-of-record (if required by IRB policies and procedures); b) the Request Form provides for the same; and (c) the subcontractor has signed a data release agreement with MCW (or other agreement as MCW determines necessary).
7. Publications.
7.1 Before submitting an abstract, manuscript, or other aggregation data to another party for presentation or publication, Recipient must submit the same to the CRDW for review to ensure compliance with the terms of this Agreement. The CRDW shall respond within 30 calendar days. If the abstract, manuscript, or data aggregation does not, in the CRDW’s sole discretion, reflect compliance with the terms of this Agreement, Recipient will revise and resubmit to the CRDW prior to presentation or publication. Promptly upon publication, Recipient shall provide a copy of the final work and a complete citation to the CRDW. Recipient agrees to acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of the Southeastern Wisconsin Clinical and Translational Science Institute resources by including the NIH Funding Acknowledgement.
7.2 All publications using or referencing the Data must contain the standard disclaimer, “The data reported here have been supplied by the Medical College of Wisconsin Clinical Research Data Warehouse. The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy of or interpretation by the Medical College of Wisconsin.” As applicable, such publications should also include references to the investigators who deposited the Data into the CRDW and to those investigators’ respective, relevant publications.
8. Data Access. Only those individuals listed on the Request Form shall access identified Data, and all such individuals shall be advised of the terms of this Agreement and the restrictions upon use and disclosure. The names of any additional individuals who desire to access the Data shall be added to the Request Form, which shall be resubmitted to the CRDW for review and approval prior to such individuals receiving access to the Data. Request Forms must also be updated and resubmitted to the CRDW to reflect any individuals originally approved for access who will no longer be permitted to access the Data. The aforementioned requirements shall continue for the duration of the Research Study. Recipient shall be ultimately responsible for the actions and inactions of the individuals accessing the Data.
9. Confidentiality. Recipient acknowledges that the Data are private, confidential and proprietary, and that unauthorized use is a violation of the terms of this Agreement and is prohibited.. The Recipient has in place, and shall maintain during the term of this Agreement and for so long as the Data (or copies thereof) are in its possession and control, appropriate administrative, technical, procedural, and physical safeguards sufficient to protect the confidentiality of the Data and to prevent unauthorized access to and/or use of the same.
10. Destruction of Data. Promptly upon completion of the Research Study or when Data ceases to be used in connection with the Research Study, whichever is later, Recipient shall return the Data to the CRDW, or shall certify in writing to the CRDW that the deletion and destruction of all copies of the Data, and all work product or information derived from the Data, have been completed. Notwithstanding the foregoing, Recipient may retain one copy of the Data for its internal records. This retention must be included in the written certification to the CRDW referenced in this section.
11. Modifications to Research Studies
11.1 If there are changes in or to the Research Study and/or Protocol, the Recipient must provide to the CRDW an updated Request Form, including details of the Research Study modifications and/or the modified Protocol. The CRDW may approve or reject such changes, in its sole discretion. In the event the CRDW approves the changes, this Agreement shall be updated via signed amendment to reflect the same, only after which Recipient may implement the changes into the Research Study or Protocol.
11.2 In the event Recipient becomes employed by another institution, not MCW, during the term of the Research Study, a new Data Release Agreement must be executed. This must occur before Data may be accessed at or taken to the new place of employment.
12. Violation of this Agreement. In the event MCW or the CRDW become aware of violations of the terms of this Agreement or use of the Data or any part of it that is not authorized under this Agreement, or which is contrary to applicable laws, MCW or the CRDW may notify the Recipient to end the violation and cure the breach. MCW or the CRDW may also: 1) terminate this Agreement immediately at which point all Data shall be promptly returned to the CRDW or destroyed (the latter of which must be certified in writing to the CRDW); and / or 2) disqualify (in whole or in part) the Recipient at fault and/or any authorized individuals from receiving CRDW Data in the future.
13. Compliance with Laws. The provision by the CRDW and use by Recipient of the Data shall comply with all applicable laws, rules, regulations, MCW policies and the terms of this Agreement. This Agreement consists of the Request Form and all forms attached thereto, the terms and conditions stated herein, the CRDW Data Use Policy and other applicable MCW polices. Any other terms and conditions, including those which are handwritten, shall be null and void.
14. Assignment. This Agreement may not be assigned by either party.